Prednisone Patent Expiration

Prednisone is Used for managing a variety of inflammatory and autoimmune conditions including rheumatoid arthritis and allergic reactions. It was first introduced by Schering Corp Sub Schering Plough Corp in its drug Meticorten on Approved Prior to Jan 1, 1982. Other drugs containing Prednisone are Rayos, Prednisone, Deltasone, Paracort. 64 different companies have introduced drugs containing Prednisone.


Prednisone Patents

Given below is the list of patents protecting Prednisone, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Rayos US8168218 Delayed release tablet with defined core geometry Jan 07, 2028 Horizon
Rayos US9504699 Delayed-release glucocorticoid treatment of rheumatoid disease Aug 03, 2027 Horizon
Rayos US8309124 Delayed release tablet with defined core geometry Apr 23, 2024

(Expired)

Horizon
Rayos US8394407 Delayed release tablet with defined core geometry Apr 23, 2024

(Expired)

Horizon
Rayos US9040085 Delayed release tablet with defined core geometry Apr 23, 2024

(Expired)

Horizon
Rayos US9186332 Delayed release tablet with defined core geometry Apr 23, 2024

(Expired)

Horizon
Rayos US6488960 Corticosteroid formulation Mar 14, 2020

(Expired)

Horizon
Rayos US6677326 Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration Mar 14, 2020

(Expired)

Horizon



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Prednisone's patents.

Given below is the list recent legal activities going on the following patents of Prednisone.

Activity Date Patent Number
Patent litigations
Expire Patent 14 Apr, 2025 US8394407(Litigated)
Refund - Payment of Maintenance Fee, 12th Year, Large Entity 14 Jan, 2025 US8309124(Litigated)
Refund - 11.5 yr surcharge - late pmt w/in 6 mo, Large Entity 14 Jan, 2025 US8309124(Litigated)
Maintenance Fee Reminder Mailed 28 Oct, 2024 US8394407(Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 24 May, 2024 US8309124(Litigated)
11.5 yr surcharge- late pmt w/in 6 mo, Large Entity 24 May, 2024 US8309124(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 23 May, 2024 US9504699
Payment of Maintenance Fee, 12th Year, Large Entity 24 Oct, 2023 US8168218(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 09 May, 2023 US9186332
Payment of Maintenance Fee, 8th Year, Large Entity 16 Nov, 2022 US9040085


About Veterinary Prednisone

Prednisone is used in a drug marketed by 1 company: Intervet Inc.

Other drugs containing Prednisone are: Meticorten .

Prednisone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Prednisone:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Study of Sirolimus in Idiopathic Retroperitoneal Fibrosis Peking University International Hospital NA COMPLETED
(Sep 1, 2026)
PHASE2, PHASE3
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Ivarmacitinib Versus Glucocorticoids in Mild-to-Moderate Systemic Lupus Erythematosus Chinese SLE Treatment And Research Group NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT) M.D. Anderson Cancer Center NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer National Cancer Institute (NCI) NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone Ivan de Kouchkovsky, MD NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Aug 1, 2026)
PHASE2
A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK) M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of VV-14305 for the Treatment of Thyroid Eye Disease Kriya Therapeutics, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Efficacy of Bimekizumab in Adults With Pyoderma Gangrenosum Oregon Health and Science University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Administration of Anti-CD19-chimeric-antigen-receptor-transduced T Cells From the Original Transplant Donor to Patients With Recurrent or Persistent B-cell Malignancies After Allogeneic Stem Cell Transplantation National Cancer Institute (NCI) NA COMPLETED
(Jul 8, 2026)
PHASE1
The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach University of Pennsylvania NA COMPLETED
(Jul 1, 2026)
PHASE3
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE1
Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) Prevail Therapeutics NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis ECOG-ACRIN Cancer Research Group NA TERMINATED
(Jul 1, 2026)
PHASE2
Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy H. Lee Moffitt Cancer Center and Research Institute NA RECRUITING
(Jul 1, 2026)
PHASE2
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial Samer Gawrieh NA RECRUITING
(Jul 1, 2026)
PHASE2
Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis Lifordi Immunotherapeutics, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE1
Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma Washington University School of Medicine NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Jun 9, 2026)
PHASE2
A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies Canadian Cancer Trials Group NA RECRUITING
(Jun 1, 2026)
PHASE2
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation University Hospital, Montpellier NA TERMINATED
(Jun 1, 2026)
PHASE3
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) Novartis Pharmaceuticals NA COMPLETED
(Jun 1, 2026)
PHASE3
Orelabrutinib in the Treatment of Relapsed/Refractory AIHA Peking Union Medical College Hospital NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study of E6742 in Participants With Systemic Lupus Erythematosus Eisai Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE2
Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia Chinese SLE Treatment And Research Group NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas University Hospital, Montpellier NA TERMINATED
(May 1, 2026)
PHASE3
Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD) Beth Israel Deaconess Medical Center NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
Pediatric GVHD Low Risk Steroid Taper Trial John Levine NA COMPLETED
(May 1, 2026)
PHASE2
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants DualityBio Inc. NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study of IMM0306 in IgG4-Related Disease ImmuneOnco Biopharmaceuticals (Shanghai) Inc. NA NOT YET RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study Angus W. Thomson PhD DSc NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer University of Michigan Rogel Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia Princess Maxima Center for Pediatric Oncology NA RECRUITING
(Apr 1, 2026)
PHASE3
Belimumab in Autoimmune Hepatitis University Health Network, Toronto NA RECRUITING
(Apr 1, 2026)
PHASE2
Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome Assistance Publique - Hôpitaux de Paris NA RECRUITING
(Apr 1, 2026)
PHASE3
SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors Second Affiliated Hospital of Nanchang University NA RECRUITING
(Apr 1, 2026)
PHASE2
Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM) Restem, LLC. NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation University of Colorado, Denver NA COMPLETED
(Mar 1, 2026)
PHASE3
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) Janssen Research & Development, LLC NA COMPLETED
(Mar 1, 2026)
PHASE2
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma University of Michigan Rogel Cancer Center NA RECRUITING
(Mar 1, 2026)
PHASE2
Subcutaneous Abatacept in Renal Transplant Recipients Idelberto Badell NA COMPLETED
(Mar 1, 2026)
PHASE1
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) Oregon Health and Science University NA RECRUITING
(Mar 1, 2026)
PHASE2
Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo Xijing Hospital NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Prednisone Generic API Manufacturers

Several generic applications have been filed for Prednisone. The first generic version for Prednisone was by Hikma Pharmaceuticals Usa Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Dr Reddys Laboratories Ltd and was approved on Jun 26, 2026.

Given below is the list of companies who have filed for Prednisone generic, along with the locations of their manufacturing plants worldwide.